Doc,
We know that St. Gobain's Glasswork is lined up to provide the disposable cassettes, I've got to believe they know who'll manufacture the actual units, if they don't have the capability themselves. I suspect that many of the parts that go into the unit can be purchased directly from manufacturers they've already identified.
In that we don't know how close they are to gaining approval for the device, if they feel certain of approval, perhaps they've already built substantial quantities of the units, and ordered many disposable cassettes to go with them.
Gary